The United States Food and Drug Administration (US FDA) concluded its inspection of Unit-II, a formulation manufacturing facility of Eugia Pharma Specialities Ltd. (a wholly-owned subsidiary of Aurobindo Pharma) in Bhiwadi, Alwar, Rajasthan on November 14, 2025. The inspection, which began on November 3, 2025, resulted in 9 observations, which are procedural in nature and will be addressed within the stipulated timeframe.
Inspection Overview
The US FDA conducted an inspection at Unit-II of Eugia Pharma Specialities Ltd., located in Bhiwadi, Alwar, Rajasthan. Eugia Pharma Specialities Ltd. is a wholly-owned subsidiary of Aurobindo Pharma. The unit is a formulation manufacturing facility.
Inspection Details
The inspection took place from November 3, 2025 to November 14, 2025. At the conclusion of the inspection, a total of 9 observations were issued. The company states that these observations are procedural in nature. Aurobindo Pharma is committed to maintaining high-quality manufacturing standards across its facilities.
Response and Impact
The company is planning to respond to the observations within the stipulated timeframe. The company also stated that this development will not have any impact on the existing operations of the Unit.
Source: BSE
